Electrochemical test sensor
First Claim
1. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
- a base;
a first electrode on the base including a first conductor and a first reagent layer, the first reagent layer including a mediator having a deposition density of at most 5 μ
g/mm2 and an enzyme system having a deposition density of at most 0.5 μ
g/mm2;
a second electrode on the base; and
a lid, the lid and the base assisting in forming an opening to receive the fluid sample,wherein the biosensor provides a determined concentration value having a stability bias of less than +/−
10% after storage at 50°
C. for 2 weeks when compared to a comparison biosensor stored at −
20°
C. for 2 weeks.
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Accused Products
Abstract
The present invention relates to electrochemical sensor strips and methods of determining the concentration of an analyte in a sample or improving the performance of a concentration determination. The electrochemical sensor strips may include at most 8 μg/mm2 of a mediator. The strips, the strip reagent layer, or the methods may provide for the determination of a concentration value having at least one of a stability bias of less than ±10% after storage at 50° C. for 4 weeks when compared to a comparison strip stored at −20° C. for 4 weeks, a hematocrit bias of less than ±10% for whole blood samples including from 20 to 60% hematocrit, and an intercept to slope ratio of at most 20 mg/dL. A method of increasing the performance of a quantitative analyte determination also is provided.
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Citations
28 Claims
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1. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a first reagent layer, the first reagent layer including a mediator having a deposition density of at most 5 μ
g/mm2 and an enzyme system having a deposition density of at most 0.5 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a stability bias of less than +/−
10% after storage at 50°
C. for 2 weeks when compared to a comparison biosensor stored at −
20°
C. for 2 weeks. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 2 μ
g/mm2 and an enzyme system having a deposition density of at most 0.5 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a stability bias of less than +/−
10% after storage at 50°
C. for 2 weeks when compared to a comparison biosensor stored at −
20°
C. for 2 weeks.
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12. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 5 μ
g/mm2 and an enzyme system having a deposition density of at most 0.5 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a hematocrit bias of less than +/−
10% for whole blood samples including from 20 to 60% hematocrit. - View Dependent Claims (13, 14, 15, 16)
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17. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 2 μ
g/mm2 and an enzyme system having a deposition density of at most 0.5 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having a hematocrit bias of less than +/−
10% for whole blood samples including from 20 to 60% hematocrit.
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18. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base having at least one first layer on a first conductor, the first layer including a reagent layer comprising at most 5 μ
g/mm2 of a mediator, and an enzyme system at a deposition density of at most 0.5 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having an intercept to slope ratio of at most 20 mg/dL. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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25. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base having at least one first layer on a first conductor, the first layer including a reagent layer comprising at most 2 μ
g/mm2 of a mediator, and an enzyme system at a deposition density of at most 0.8 μ
g/mm2;a second electrode on the base; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample, wherein the biosensor provides a determined concentration value having an intercept to slope ratio of at most 20 mg/dL.
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26. A method of determining the concentration of an analyte in a fluid sample, the method comprising:
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applying the fluid sample to an electrochemical biosensor, the biosensor including a base, a first electrode, a second electrode and a lid, the first electrode on the base including a first conductor and a reagent layer, the reagent layer including a mediator having a deposition density of at most 8 μ
g/mm2 and an enzyme system having a deposition density of at most 0.8 μ
g/mm2, the second electrode on the base, the lid and the base assisting in forming an opening to receive the fluid sample;applying a pulse sequence to the sample; determining current measurements from the sample responsive to the pulse sequence; and determining the concentration of the analyte in the sample from the current measurements, the determined concentration having at least one of a stability bias of less than +/−
10%, a hematocrit bias of less than +/−
10% for whole blood samples over a 20 to 60% hematocrit range, and an intercept to slope ratio of at most 20 mg/dL.
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27. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a reagent layer comprising from 1.72 to 2 μ
g/mm2 of a mediator and an enzyme system having a deposition density from 0.42 to 0.8 μ
g/mm2;a second electrode; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample.
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28. An electrochemical biosensor for determining an analyte concentration in a fluid sample, the biosensor comprising:
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a base; a first electrode on the base including a first conductor and a reagent layer, the reagent layer including a reagent layer comprising from 1.72 to 8 μ
g/mm2 of a mediator and an enzyme system having a deposition density from 0.42 to 0.8 μ
g/mm2;a second electrode; and a lid, the lid and the base assisting in forming an opening to receive the fluid sample.
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Specification